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Completed

NCT Number: NCT04741828

Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian

Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.

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Key information

Conditions

Vaccine

Age range

6 month–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Puskesmas Jatinegara, Jakarta, Indonesia

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About this study

This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy.
  • Subject who completed the phase II Vi-DT study (Typhoid 0218)
  • Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
  • Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion criteria

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial.
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC).
  • Known history of allergy to any component of the vaccines.
  • History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
  • Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.

Treatment and study plan

Vi-DT Typhoid Conjugate Vaccine

Drug

Typhoid Conjugate Vaccine

Primary outcomes

  1. To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants

    Time frame: 2 years + 2 months after primary dose

    Percentage of adults, adolescent, children and infants with seroconversion defined as >= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline.

Secondary outcomes

  1. To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.

    Time frame: 28 days (-4/+14D)

    Percentage of subject aged 6-23 months old at primary dose with seroconversion defined as >= 4 fold in antibody titer 28 days after booster dose compared to pre booster dose.

  2. To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.

    Time frame: 28 days (-4/+14D)

    Percentage of subject with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours, 7 days and 28 days after booster dose.

  3. To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.

    Time frame: 5 years

    Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to baseline.

  4. To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.

    Time frame: 3 years

    Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to before booster.

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Collaborators

  • Indonesia University

Registry information

Official study title

Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2021
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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